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newman2021

03/18/22 1:44 PM

#452481 RE: Maverick0408 #452475

oh you believe UK and Germany will approve but why they won't this year? What is stopping them? Are they some hypocrites??
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hoffmann6383

03/18/22 1:59 PM

#452493 RE: Maverick0408 #452475

shareholders that claim to know what the ra's will or will not approve over the next 9.5 months are disguising baseless speculation as fact. we have no idea what the ra's will do.
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skitahoe

03/19/22 12:07 AM

#452602 RE: Maverick0408 #452475

Mav,

We're less than 1/4 through the year. I believe all 4 regulators try to act on BLA's in 6 months, and sometimes they do substantially better than that. To me this means the company still has over 3 months to submit their BLA's and an approval from one or more could come this year.

I don't have the foggiest idea how close they are, or if they are waiting for action on the FlaskWorks unit to be approved before making the submission.

I certainly can't guarantee that we'll have one or more approvals prior to the end of the year, but at this point it's not impossible for us to get all four. Let's wait to see what we know by July, if at least one BLA hasn't been filed by then approval this year becomes unlikely, though it's possible the U.K. could get it done in 4 months or less.

Gary